Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2012-02-29
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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test product 1 first
own product (baseline) - test product 1 - test product 2
test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1
test product 1: new ostomy base plate with Coloplast as manufacturer
test product 1 is tested first
test product 2 first
own product (baseline) - test product 2 - test product 1
test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2
test product 2: new ostomy base plate with Coloplast as manufacturer
test product 2 is tested first
Interventions
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test product 1: new ostomy base plate with Coloplast as manufacturer
test product 1 is tested first
test product 2: new ostomy base plate with Coloplast as manufacturer
test product 2 is tested first
Eligibility Criteria
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Inclusion Criteria
2. Have had an ileostomy for more than 3 months.
3. Have used convex products for the last 1 month.
4. Has given written Informed Consent.
5. Have an ileostomy with a diameter between 15 and 33 mm.
6. Have inward peristomal area
Exclusion Criteria
2. Pregnant or breastfeeding.
3. Known allergy towards any of the product components or ingredients.
4. Currently receiving or have within the last 2 months received radio- and/or chemotherapy.
5. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
6. Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Locations
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Coloplast A/S
Humlebæk, Denmark, Denmark
Countries
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Other Identifiers
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CP226
Identifier Type: -
Identifier Source: org_study_id
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